Politics

A former farm worker named Enrique Rubio may just be the right “David” to take down “Goliath” chemical company Monsanto. Rubio filed suit against the manufacturer of Roundup® early last week, claiming that the company’s infamous herbicide is the cause of his bone cancer and inability to work.

Roundup’s® safety has been hotly debated for years among scientists, environmental activists and those concerned with human health. Rubio’s suit, if successful, may put an end to that debate once and for all by forcing Monsanto to provide proof that it knowingly withheld data on the true dangers of its flagship product.

The active ingredient in Roundup®, a nasty chemical called glyphosate, was discovered in 1970. Rubio’s suit states that [g”]lyphosate is a broad-spectrum, non-selective herbicide used in a wide variety of herbicidal products around the world. Plants treated with glyphosate translocate the systemic herbicide to their roots, shoot regions and fruit, where it interferes with the plant’s ability to form aromatic amino acids necessary for protein synthesis. Treated plants generally die within two to three days. Because plants absorb glyphosate, it cannot be completely removed by washing or peeling produce or by milling, baking, or brewing grains.”

Monsanto claimed glyphosate was “a technological breakthrough: it could kill almost every weed without causing harm either to people or to the environment.” However, that doesn’t seem to be the case. The World Health Organization (WHO) asserts that glyphosate is “a probable cause of cancer.”

Why would Monsanto take such a big risk? Money. The company needed a win in the industry in order to continue its “reputation and dominance in the marketplace. Largely due to the success of Roundup® sales, Monsanto’s agriculture division was out-performing its chemicals division’s operating income, and that gap increased yearly.” So, rather than go with a less toxic product, Monsanto sold humanity and the planet for its own bottom line.

Wait, a less toxic product? Is that possible? Indeed, it is possible and was possible from Day One. “The harm caused by [Monsanto’s] Roundup® products far outweighed their benefit. …Roundup® products were and are more dangerous than alternative products and {the company] could have designed its Roundup® products to make them less dangerous. Indeed, at the time that [Monsanto] designed its Roundup® products, the stat of the industry’s scientific knowledge was such that a less risky design or formulation was attainable.”

So basically, Monsanto decided it was better (for it) to release a carcinogenic product that it was to spend a bit more money taking the time to research a less harmful alternative. The sad thing is, knowing that its product was dangerous, Monsanto had to pull some serious strings to get it approved.

The EPA originally classified glyphosate as “possibly carcinogenic to humans” in 1985. However, “after pressure from Monsanto, including contrary studies it provided to the EPA, the EPA changed its classification to evidence of non-carcinogenicity in humans in 1991.”

The “contrary studies” involved two “independent” labs that willfully committed scientific fraud. The FDA inspected one lab, Industrial Bio-Test Laboratories (IBT), in 1976. That inspection uncovered “discrepancies between the raw data and the final report relating to the toxicological impacts of glyphosate.”

This prompted the EPA to do its own audit. The EPA found the same results. Moreover, one EPA reviewer said that, “after finding ‘routine falsification of data’ at IBT, that it was ‘hard to believe the scientific integrity of the studies when they said they took specimens of the uterus from male rabbits.’” Unsurprisingly, three of IBT’s top executives were convicted of fraud in 1983.

The other lab, Craven Laboratories, was hired by Monsanto to perform additional tests on glyphosate in 1991. “In that same year, the owner of Craven Laboratories and three of its employees were indicted, and later convicted, of fraudulent laboratory practices in the testing of pesticides and herbicides.”

According to Rubio’s complaint, “Despite the falsity of the tests that underlie its registration, within a few years of its launch, Monsanto was marketing Roundup® in 115 countries.” Nowadays, Monsanto’s glyphosate products can be found in 130 countries and are approved for use on over 100 different crops. If you think that you’re safe, think again.

“[Glyphosate products] are ubiquitous in the environment. Numerous studies confirm that glyphosate is found in rivers, streams, and groundwater in agricultural areas where Roundup® is used. It has been found in food, in the urine of agricultural workers, and even in the urine of urban dwellers who are not in direct contact with glyphosate.”

The New York Attorney General sued Monsanto in 1996 claiming its Roundup® advertising was “false and misleading.” The suit specifically challenged “Monsanto’s general representations that its spray-on glyphosate-based herbicides, including Roundup®, were ‘safer than table salt’ and ‘practically non-toxic’ to mammals, birds, and fish.”

Monsanto agreed, in 1996, to “cease and desist from publishing or broadcasting any advertisements [in New York].”

Various other governments have either severely restricted or outright banned the sale of Roundup®, including the Netherlands, Brazil, France, Bermuda, Sri Lanka and Columbia.

Indeed, this may be the beginning of the end for Monsanto and Roundup®. One can only hope that justice will prevail in Rubio’s case and the chemical giant will be forced to tell the truth and face the consequences.

Published Friday January 24th 2014, the report begins by citing a recent Gallup poll demonstrating a recent and dramatic decline in the number of Americans without health insurance. Likely the result of the further implementation of the Affordable Care Act, Yglesias purports “that progress is likely to continue.”

With the increasing number of Americans receiving health insurance, we must also be mindful of the quality of that care received. Yglesias cites a few positive reforms mandated by ACA, “designed to restrain aggregate health care spending, most notably by reforming the way Medicare pays medical providers.” Though, the author notes that “health care spending has been slowing down in recent years, and there’s some evidence that Obamacare deserves the credit”, but “that slowdown was happening before the major expansion of insurance coverage kicked in.”

This is good news either way, but it doesn’t speak to whether the current healthcare system is as yet capable of handling millions of new, recently-insured patients. Yglesias writes “The Affordable Care Act relies on Medicaid expansion to cover many new people because Medicaid is one of the cheapest ways to deliver health insurance. But the main reason it’s so cheap is that its payments to health care providers are relatively stingy. Since the payments are stingy, some providers refuse to treat Medicaid patients. Since Obamacare gives non-Medicaid insurance to many currently uninsured people, providers may actually find it easier than ever to fill their schedules with high-paying non-Medicaid customers—even at a time when Medicaid expansion means we need more providers.”

Next, Yglesias discusses the role of nurse practitioners in the healthcare system. Currently, a number of states – the author cites Maryland, Rhode Island, Idaho, and Utah – “allow nurse practitioners to diagnose and treat a variety of ailments without a doctor’s involvement.” And though larger states such as New York, Florida, California, and Texas do not, “Evidence suggests that health outcomes are no worse for patients treated by independent nurse practitioners.” If more states allow nurses to work with increased autonomy, more patients would be able to be treated, and for less cost. Further, the ability for states to produce, as it were, more healthcare professionals would rise dramatically, as, simply put, it is “easier to qualify as a nurse practitioner than as an M.D.”

Another issue noted to consider is the current trend for hospital mergers. While in some cases justified, hospital mergers may create diminished competition leading to price gouging, even if only at the local level. “Federal antitrust regulators haven’t traditionally had much to say about the health care industry, but that needs to change.”

And finally, Yglesias advocates for an increased supply of doctors. “American doctors are paid more than doctors in almost any other country, and yet we have fewer doctors per capita.” Among the avenues for solution cited are relaxed immigration policies for foreign physicians, particularly general practitioners, and a call to train more doctors domestically. “Medical schools have gotten steadily more selective over the past generation rather than expanding with the size of the population, and Congress has refused to pony up the money to finance more residencies.”

Though passing legislation for any of these improvements will likely be difficult, a positive aspect to all of them is a lack of inherent political divide, as was the case with the Affordable Care Act. Hopefully moving forward our country will create the capacity to treat all our nation’s sick, whatever their socioeconomic background.

To that end, Congress passed the Drug Quality and Security Act (DQSA) on 11/27/2013, a law with two aims: to ensure the quality of compounded drugs, and to ensure the security of compounded drugs. Toward the goal of ensuring drug quality, the law “Establishes annual registration requirement for any outsourcing facility” (for clarity, “outsourcing facility” means compounding pharmacy), “Requires a facility to report biannually to the Secretary of Health and Human Services (HHS) on what drugs are compounded in the facility and to submit adverse event reports”, and “Subjects such facilities to a risk-based inspection schedule.” (DQSA)

Toward the goal of ensuring drug security, the law “Establishes requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain” (DQSA). According to an article by FDA Commissioner Dr. Margaret Hamburg, this will be a stepwise process taking ten years to become fully effective. At that point, the law “will require manufacturers, repackagers, wholesale drug distributors, and dispensers (other than most licensed health care practitioners) to provide product and transaction information with each sale and notify the FDA and other stakeholders of illegitimate products, which will result in improved detection and removal of potentially dangerous drugs from the supply chain.”

Jill Wechsler, Washington editor of the Pharmaceutical Technology blog, PharmaTech Talk, writes that of yet (just three months after the passage of DQSA), only 14 compounding pharmacies have registered with the FDA – of over 3,000 currently operating in the United States. However, these figures ought not to be discouraging, she writes, as “this initial activity reflects FDA’s fast action in implementing the Drug Quality and Security Act”.

Further, there is a disincentive for compounding pharmacies to register with the FDA including significant fees and the obligation to submit to federal regulations and inspections, and Wechsler writes the FDA is currently implementing three strategies to encourage compounding pharmacy registration. First, the FDA is asking “hospitals to exert their purchasing power to compel compounders to embrace the new regulatory system” by sending letters to “hospitals urging them to pressure the compounding pharmacies they buy from to sign up as outsourcing facilities. Support for this approach was recently voiced by executives at the Premier hospital system, which purchases drugs for hundreds of hospitals.”

Next, Commissioner Hamburg has sent letters to state governors and “members of state boards of pharmacy and state health officials” touting the benefits of the Drug Quality and Security Act, seeking state assistance in “dealing with distant compounders that ship into a state.”

Though there are certain disincentives for compounding pharmacies to register with the FDA, it must be made clear the possibilities of their commercial benefit and legal protection await.

Lastly, the FDA is aiming to encourage compounding pharmacy registration by re-establishing Pharmacy Compounding Advisory Committee, which will make new regulations. The committee will likely be composed of “leading experts in the field” and “nonvoting representatives of pharmaceutical manufacturers and of pharmacy compounders.”

Wechsler concludes, “One important task for FDA is to develop lists of drugs that may not be compounded and lists of bulk drug substances that comply with established standards and thus may be used in compounding. FDA plans to issue new regulations to update these lists. The agency also will continue proactive and for-cause inspections of compounding pharmacies and will ‘take aggressive action’ when necessary to protect the public health.”

Though I find it incredible that compounding pharmacies had not as yet been subject to federal inspection and other such requirements, DQSA is absolutely a step in the right direction.

It is no secret that Americans pay some of the highest prices for pharmaceutical drugs in the world. And, while the Affordable Care Act will help maybe 50 million uninsured Americans secure health insurance, that law will have no effect on the overall price of medication.

Soaring drug prices are likely the result of a variety of problems, such as inefficiencies in drug manufacturing and the high standard of research applied to each medication sold, but also result from simple price gouging and the tactics of trade groups such as PhRMA – a lobbying organization with an income of over $200 million in 2010.

This new bill, called “Personal Drug Importation Fairness Act of 2013,” proposed in the US House of Representatives and sponsored by Keith Ellison (D-MN), Jan Schakowsky (D-IL), and Dana Rohrabacher (R-CA), would allow individuals in the US to import drugs from “Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and countries in the European Union, since these are believed to have safety standards comparable to the US”, reports Ed Silverman of Forbes.

And this isn’t, we should note, a new idea. Already this past year, the state of Maine passed a law allowing its citizens to import drugs from internet pharmacies in the UK, Canada, Australia, and New Zealand. Of course, this law received immediate push-back from PhRMA and other trade groups in lawsuits that alleged such laws circumvent FDA scrutiny and as such (are illegal and) place Americans at risk.

Ignoring the fact that it’s a little insulting to those countries – declaring that their drug safety standards are too low for American bodies, it seems that it might be a little more unhealthy for Americans to be starved of essential medications due to cost prohibition.

All of that is moot anyway, for in response to those allegations concerning the Maine law, the FDA claimed it will only allow the import of medications it has already approved.

Ed Silverman quotes the new bill’s Minnesota sponsor Keith Ellison as stating the bill will “‘allow Americans to spend more time focusing on their health and less time worrying about how they’ll pay for their prescriptions’”.

Of course, whether or not this bill will get off the ground has yet to be seen. I hope it does.

This article cites new research that found Oregon users of Medicaid, “the publicly funded health insurance program for the poor — are 40 percent more likely to use emergency rooms than people with no insurance.”

Amy Finkelstein, an MIT professor and an author of that study states, “‘When you cover the uninsured, emergency room use goes up by a large magnitude’” and remarks “‘In no case were we able to find any subpopulations, or type of conditions, for which Medicaid caused a significant decrease in emergency department use.’”

That study also found that it is common for Medicaid users to seek emergency room care for conditions that “might be more easily treated in a doctor’s office.”

Here are some of the issues: people using Medicaid often work several jobs and thus are not available to see primary care physicians during normal operating hours. Next, a point made by Julie Rovner of NPR, citing the “director of state policy and programs for the National Association of Medicaid Directors,” Kathleen Nolan, is that “Because Medicaid recipients are by definition low income, Medicaid doesn’t use higher patient payments to deter emergency room use like many private insurers do”.

Rovner cites Nolan, stating “the key to getting inappropriate costs down for all patients, she says, is educating people about where they should go when it’s not an emergency.” I agree.

While this problem continues to exist, Jonathan Blum (Principal Deputy Administrator for Centers for Medicare and Medicaid Services) remains “committed to making improvements,” stating “‘We look forward to working with Congress and the HHS Inspector General to continue to protect beneficiaries and taxpayers from Medicare fraud, waste and abuse’”.

Hopefully, closing of loopholes such as this will bring down the total cost of healthcare moving forward.

According an interview with Julian Hattem of RegWatch, “The Hill’s Regulation Blog,” “DeLauro is concerned that poor food safety regulations in some countries taking part in the talks could put Americans at risk and said that a process being supported by the U.S. Trade Representative would ‘further jeopardize food safety.’

‘This is an area where I believe that trade is trumping public health in a very significant way,’ DeLauro said Thursday. [ ] She added that the Obama administration is not taking a long-term strategy to protect food safety in the trade deal by beefing up domestic inspection efforts.

‘This deal will lead to an influx of seafood imports from Asia, and we should therefore enhance funding for food safety at the FDA,’ she said. ‘We’re at a government shutdown here at the moment. They’ve been trying to starve FDA of resources at the best of times.’” [Full article: House Dem: Asia trade deal would threaten food safety]

Watchdog organization Food and Water Watch makes the following statement on the TPP: “The Trans-Pacific Partnership (TPP) and the Transatlantic Free Trade Agreement (TAFTA) would lead to increased gas exports and imported foods, while weakening our nation’s domestic laws and increasing the financialization of nature. Ten Pacific Rim countries and the United States are currently negotiating the TPP, while TAFTA is between the United States and the European Union. Both are advertised as bold new ways to eliminate tariffs, import quotas and preferences on goods and services. And if put into action, they’ll serve as the models for future global trade deals.

In reality, the TPP and TAFTA are power grabs by corporations and their financers. They would challenge laws that protect the environment, rein in corporate interests, protect food safety, promote renewable energy, and curb risky practices such as fracking.”

Though allegations of a corporate power grab may be questionable, Food Safety News references a letter by Congresswoman Rosa DeLauro, Senator Mary Landrieu (D-LA) and Congressman Walter Jones (R-N.C.), submitted to U.S. Trade Representative Ron Kirk, that in a push to secure tighter food safety laws for imports from Malaysia and Vietnam, cites in FY2012, “imported seafood products from Vietnam, the fifth largest exporter of shrimp to the United States, were refused entry 206 times because of concerns including filth, decomposition, drug residues, unapproved food additives and Salmonella.” Clearly, we have reason to maintain strict safety standards for food imports.

So, while expansions in free trade can be beneficial to a single nation’s economy or the international economy, it is important that we do not overlook the costs at which such expansions may come. For more information on the Trans Pacific Partnership and its impact on food safety, follow the links below.

A recent article published by Forbes.com purports that Obamacare is harming the American healthcare system. While the healthcare system we had before the Affordable Care Act was not perfect, it was more fundamentally sound than after the ACA took effect. Problems with U.S. Health Care System should have been closely examined in 2009 and appropriate changes could have been made but the Obama administration failed to focus on the positive aspects of the U.S. Health Care System and fundamentally changed the way it works. Obama took away fiscal incentives, the drive to create the best medicines, and the need to provide high quality patient care. A healthcare provider who has the most advanced medicine practices and the best medicines available will be worth more to the general public, and thus Howard believes this incentive-based drive to be the best is no longer applicable as the fact that the government is taking over the entire system.

Forbes reports that before the Affordable Care Act was installed, as much as 80 percent of American citizens were happy with the care they were receiving. Of course, before the ACA, many Americans had no health insurance – thus no healthcare to be happy or sad about.

Obama told the American public that his system would not force anybody to lose their plan and make them shift over to Obamacare. We now see that this is not exactly the case. Only time will tell whether the care provided to those required to switch coverage plans will have been for the better. Paul Howard of Forbes believes that as the Affordable Care Act takes some of the choice out of healthcare, the overall quality of the American healthcare system will sharply decline. This too is yet to be seen.

Howard also purports that the invention of new medications will drastically slow because the pharmaceutical companies that develop these medications won’t have any incentives to be the best: let the private health care system that created the world’s best medical therapies in the world do its job.

The wide range of tools the internet can provide has proven problematic in the regulation of prescription drugs that are sold from online pharmaceutical companies based in foreign countries. Counterfeit drugs have exploded onto the scene and as reported by Forbes, the worldwide market for these drugs is estimated to be worth 75 billion dollars. Maine has recently passed a law allowing the importation of these non-approved FDA drugs to be sold from countries such New Zealand and Australia. Drug companies are worried their reputations will be lost if subprime medications make their way onto the American scene.

Price control of prescription drugs is seen in most developed and wealthy nations, and despite the U.S. being both wealthy and developed, there are no price controls on prescription drugs. Prices of certain medications are much higher in America than in other countries in which the government sets controls. And as such, many Americans are not happy about the fact that they are paying a higher price for the same medications that people in other countries are buying.

There are systems in other countries that work to get cheaper medications to their citizens: some European countries funnel cheaper drugs from poorer countries like Greece through systems of parallel trade. Recently, drug companies have begun to delay the exportation of their newer, more expensive drugs to poorer countries in order to combat the black market selling of their drugs to wealthier companies.

Unfortunately, this parallel trade gives rise to selling and making of fake and sometimes dangerous drugs. Many of these fake drugs have made their way to the United States. One example of these fake drugs are fake doses of Avastin, which is a cancer drug.

These fake drugs have gotten so hard to detect, that even the drug’s manufacturer may have a difficult time sorting through real and counterfeit pills. It is for this reason the FDA has said it cannot adequately ensure the safety of drugs that are coming from foreign countries.

A recent article by Eric Palmer of the pharmaceutical news website FiercePharmaManufacturing.com writes that some trade groups, including PhRMA are trying to overturn a law passed unanimously in Alameda County, California that requires pharmaceutical manufacturers to pay for a medication “recycling” program for currently in place in the San Francisco Bay area.

As the law makes the cost of disposal of unused and expired drugs fall on pharmaceutical companies, of course pharmaceutical companies have been pushing to overturn since its inception a year ago. Currently, PhRMA is appealing a ruling by the federal district court in San Francisco that upheld the law. If the appeal maintains its current course, it will take place in April 2014 in the 9th Circuit court of Appeals. PhRMa, BIO, and the Generic Pharmaceutical Association claim that the industry is not adequately suited to be responsible for drug disposal. Drug companies and trade groups purport that the new law is forcing them away from their core business and forcing undue responsibilities.

As it currently stands, there are 28 sites where residents can drop off their unused and old medication and the price of the current program is around $330,000 a year. Part of the new law states that the companies are not allowed to cover the cost with a local point-of-sale fee, and thus PhRMA claims the law is unconstitutional because other American citizens will have to cover the cost. U.S. District Judge Richard Seeborg of San Francisco disagreed with this constitutionality argument and reports that the law is fair and treats all drug companies the same.

The pharmaceutical companies have a point: one citizen should not be forced to pay for something another citizen does. However, I believe that drug companies should pay for everything related to their products, and because determining specifically which company’s drugs are being recycled more is exceedingly cumbersome, drug manufacturers should divide the costs of the recycling program based on local market share. Though that is not a simple task, it ought to be undertaken. If Company A makes 30% of the drugs sold in the Bay area, they ought to pay for 30% of the recycling program – just food for thought.

About this Blog

This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.